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THEIR FUTURE STARTS WITH YOU HeartMate 3 LVAD with Full MagLev Flow Technology FEATURING THE FULL-COHORT ANALYSIS OF THE MOMENTUM 3 TRIAL

THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

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Page 1: THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

THEIR FUTURE STARTS WITH YOUHeartMate 3™ LVAD with Full MagLev™ Flow Technology

FEATURING THE FULL-COHORT ANALYSIS OF THE MOMENTUM 3 TRIAL

Page 2: THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

HEARTMATE 3™ LVAD DELIVERS UNPRECEDENTED* SURVIVAL AND SAFETY OUTCOMES**1

MOMENTUM 3 was the largest left ventricular assist device (LVAD) trial

ever conducted.*** The results at 2 years show that the HeartMate 3™ LVAD

continues to have:

THE HIGHEST SURVIVAL RATE FOR ANY LVAD IN A RANDOMIZED CONTROLLED TRIAL†,1-3

THE LOWEST HEMOCOMPATIBILITY-RELATED ADVERSE EVENT RATES OF ANY LVAD†,††,1-4

IMMEDIATE, SIGNIFICANT AND SUSTAINED IMPROVEMENTS IN FUNCTIONAL CAPACITY AND QUALITY OF LIFE1

See Important Safety Information referenced within.

Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.

Page 3: THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

LANDMARK SURVIVAL WITH HEARTMATE 3™ LVAD

THE GOAL OF THERAPY IS TO IMPROVE SURVIVAL AND QUALIT Y OF LIFE WHILE REDUCING COMPLICATIONS, REGARDLESS OF PRE- IMPL ANT STRATEGY. 8

Approaching that of heart transplant survival at 2 years†††5

OMM = Optimal Medical Management. Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.

BTC = Bridge to Candidacy. BTT = Bridge to Transplant. DT = Destination Therapy.See Important Safety Information referenced within.

OVERALL SURVIVAL BY THERAPEUTIC INTENT8

DTBTT/BTC

76.7%82.7%

SUR

VIV

AL

(%)

M O N T H S A F T E R I M P L A N T

82% Heart Transplant (2017)†††5

79% HeartMate 3™ LVAD (2019)1

77% HeartMate II™ LVAD (2019)1

68% HeartMate II LVAD (2017)2

58% HeartMate II LVAD DT (2009)6

24% HeartMate™ XVE LVAD (2009)6

8% OMM REMATCH (2001)7

0

100

90

80

70

60

50

40

30

20

10

06 12 18 24

Page 4: THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

THE LOWEST HEMOCOMPATIBILITY-RELATED ADVERSE EVENT (HRAE) RATES FOR ANY LVAD†,††,1-4

MOMENTUM 3 2019 ¹

HeartMate 3™ LVAD (n = 516)

HeartMate II™ LVAD(n = 512)

9.9% / 0.08 (% / EPPY)

19.4% / 0.18(% / EPPY)

MOMENTUM 3 2019 ¹

HeartMate 3 LVAD (n = 516)

HeartMate II LVAD(n = 512)

1 .0% § 11.1%§

10%

1%

S T R O K E 1

THROMBOSIS1

Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.

HRAE includes bleeding > 30 days, stroke, pump thrombosis, arterial thromboembolism, non-stroke neurological event (inconclusive or hematologic in etiology). Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only. See Important Safety Information referenced within.

HRAE refers to the constellation of bleeding, stroke and thrombosis events that often aggregate together in the same individual.

At 2 years nearly half of HeartMate 3 LVAD patients did not experience a bleeding event.4

515 342 252 203 161505 273 190 148 114

HEARTMATE 3 HEARTMATE II

No. at Risk

E N D U R A N C E 2017 2

HVAD‡ LVAD (n = 297)

HeartMate II LVAD(n = 148)

29. 7 % / 0. 29 (% / EPPY)

12.1% / 0.09 (% / EPPY)

E N D U R A N C E 2017 2

HVAD LVAD (n = 297)

HeartMate II LVAD(n = 148)

6 . 4%§ § 10.7% § §

EPPY = Events per patient-year.

SUR

VIV

AL

FRE

E O

F H

RA

E (

%)

P < 0.0001 by log-rank testHR: 0.70 (95% Cl: 0.59 –0.82) P < 0.0001

M O N T H S A F T E R I M P L A N T

60

100

90

80

70

60

50

40

0

12 18 24

45 ± 2%

58 ± 2%

45 ± 2%

32 ± 2%

Page 5: THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

OUTCOMES MADE POSSIBLE BY FULL MAGLEV™ FLOW TECHNOLOGY

• FULLY LEVITATED, SELF-CENTERING ROTOR that does not require hydrodynamic or mechanical bearings

• LARGE, CONSISTENT BLOOD FLOW PATHWAYS to reduce shear stress9

• INTRINSIC PULSATILITY (30 cycles per minute) to reduce blood stasis and minimize thrombus9,10

Full MagLev™ Flow Technology maintains gentle blood handling to

minimize complications and reduce HRAEs.

167 8STACKED RED

BLOOD CELLS11

GAP

GAP

STACKED RED BLOOD CELLS11

Full MagLev Flow Technology PumpLarge consistent blood flow pathways to reduce shear stress9

Hydrodynamic Bearing PumpNarrow blood flow pathways

vs.

See Important Safety Information referenced within.

Page 6: THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

MAKING A MEANINGFUL DIFFERENCE IN PATIENTS’ LIVES

Immediate, significant and sustained improvements in functional capacity and quality of life

Significant increase in 6-minute walk distance1

79% of patients improved from NYHA Class IIIB/IV at baseline to NYHA Class I/II by 6 months, with sustained improvement of 80% of patients through 2 years (P < 0.0001).1,12

Quality of life score improved significantly and was sustained at 2 years.1

24 MONTHS (n = 275)

80%

KCCQ SCORE(+5 POINT IS MEANINGFUL)

+30 POINTS

323 m

OVER 2X INCREASE IN DISTANCE

136 m(approx. 149 yards) (approx. 353 yards)

at 24 months (n = 211)at baseline (n = 471)

Note: One football field = 91 m (100 yards).

INDEX HOSPITALIZATION HEARTMATE 3™ LVAD (n = 515) HEARTMATE II™ LVAD (n = 505) P VALUE4

Length of stay for implant hospitalization (median days) (Q1, Q3)

19(14, 25)

17(14, 24) 0.11

Days on LVAD support outside of hospital (median) (Q1, Q3)

653(333, 696)

605(259, 690) 0.008

Readmission days in the hospital (median) (Q1, Q3)

13(4, 37)

18(6, 40) 0.02

Readmissions due to any cause (EPPY) 2.26 2.47 0.03

Significantly lower hospital readmission rate and fewer readmission days compared to HeartMate II™ LVAD12

KCCQ = Kansas City Cardiomyopathy Questionnaire.

See Important Safety Information referenced within.

Page 7: THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

HEARTMATE 3™ LVAD SYSTEMA better experience for clinicians and patients§§§

BatteriesProvide up to 17 hours of uninterrupted power

HeartMate 3™ LVADConnected to the left side of the heart and moves oxygenated blood from the left ventricle to the rest of the body

Modular drivelineFacilitates simple replacement of externalized portion

Mobile Power Unit (MPU)Plug-in power source

MAKING A MEANINGFUL DIFFERENCE IN PATIENTS’ LIVES

Quality of life score improved significantly and was sustained at 2 years.1

Pocket controller Powers and controls the LVAD and is small enough to fit in a pocket. Includes emergency backup battery

See Important Safety Information referenced within.

Page 8: THEIR FUTURE STARTS WITH YOU...2016;62:375-383. 10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the

*Based on HeartMate 3™ LVAD highest published survival and lowest published stroke and thrombosis rates in continuous-flow LVAD category of devices in the U.S.1-4

** HeartMate 3 LVAD demonstrated superiority in event-free survival(primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.

***Ongoing evaluation of more than 2,000 patients on short- and long-term therapy of devices in the U.S.1,5,6,13

†For a continuous-flow LVAD in a randomized controlled trial. ††Key adverse events include pump thrombosis, stroke and gastrointestinal bleeding.†††82% 2-year survival for heart transplant patients between 2009 and 2015.2

§Resulting in reoperation.§§Resulting in pump exchange.§§§Compared to HeartMate II LVAD.

1. Mehra M, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Ventricular Assist Device-Final Report. N Engl J Med. 2019;380:1618-1627.

2. Rogers JG, Pagani F, Tatooles A, et al. Intrapericardial left ventricular assist device for advanced heart failure. New Engl J Med. 2017;376:451-460.

3. Markham DW. Two-year Outcomes in the ENDURANCE Supplemental Trial. American Heart Association (AHA) Annual Meeting; November 10, 2018; Chicago, IL.

4. Uriel N. Long-Term Burden of Hemocompatibility Related Adverse Events in the MOMENTUM 3 Trial: Final Analysis of the 1028 Patient Cohort. The International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting; April 4, 2019; Orlando, FL.

5. Khush KK, Cherikh WS, Chambers DC, et al. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-fifth Adult Heart Transplant Report-2018; Focus Theme: Multiorgan Transplantation. J Heart Lung Transplant. 2018;37:1155-1168.

6. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-2251.

7. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001;345(20):1435-1443.

8. Goldstein DJ. Clinical Outcomes by Intended Goal of Therapy in the MOMENTUM 3 Clinical Trial: Analysis of the Full Cohort. The International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting; April 4, 2019; Orlando, FL.

9. Bourque K, Cotter C, Dague C, et al. Design rationale and preclinical evaluation of the HeartMate 3 Left Ventricular Assist System for hemocompatibility. Am Soc Artificial Int Organs. 2016;62:375-383.

10. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the proximal and distal aorta. Artificial Organs. 2006;30:638-642.

11. Abbott. Data on File.

12. Mehra MR. A Fully Magnetically Levitated Left Ventricular Assist Device-Final Report for the MOMENTUM 3 Trial. American College of Cardiology (ACC) Annual Meeting; March 17, 2019; New Orleans, LA.

13. Jorde UP, Kushwaha SS, Tatooles AJ, et al. Results of the destination therapy post-Food and Drug Administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS‡ registry (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2014;63:1751-1757.

Abbott One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000HeartMate3.com

Rx OnlyImportant Safety InformationBrief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The HeartMate 3™ Left Ventricular Assist System is indicated for providing short-and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.

Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or device thrombosis.

™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. © 2019 Abbott. All Rights Reserved. SJM-HM3-0517-0009(3) | Item approved for U.S. use only.

EMPOWERING THE TRANSFORMATION OF HEART FAILUREFrom treatment to ongoing patient management, Abbott is committed to working with you to transform heart failure and improve more patient lives.

BEAT AS ONE™

THEIR FUTURE STARTS WITH YOUBy choosing the HeartMate 3™ LVAD,

you can go above and beyond to make a meaningful difference in your patients’ lives.